Signal CMS repeals fast-track payment pathway for breakthrough medical devices

Summary

The US Centers for Medicare and Medicaid Services finalized a rule repealing the fast-track add-on payment pathway for breakthrough medical device technologies. Devices that receive FDA breakthrough designation by September 30, 2026 and marketing approval by May 1, 2028 will retain access to the existing alternative pathway through fiscal years 2028 and 2029 as a grace period. Starting with applications submitted in 2028, stricter criteria will apply, requiring devices to show substantial difference from existing technology and demonstrable clinical improvement. Once the grace period ends, newly designated breakthrough devices will need to meet these tougher conditions in order to use the alternative payment pathway. This stands in contrast to the pace at which the FDA continues approving breakthrough drugs, with the reimbursement side instead raising its bar.